BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 6890007 · Received September 25, 2017

    Report

    Report Number
    2938836-2017-31955
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 25, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN TWO PIECES. VISUAL INSPECTION REVEALED AN EXTERNAL INSULATION ABRASION ON THE DISTAL PORTION CONSISTENT WITH FRICTION BETWEEN THE LEAD AND DEVICE, BREACHING THE NON-FUNCTIONING CABLE LUMEN WITH NO DAMAGE NOTED TO THE CABLE COATING. INTERNAL INSULATION ABRASIONS WERE NOTED IN MULTIPLE LOCATIONS BREACHING THE RIGHT VENTRICULAR, RING ELECTRODE, AND NON-FUNCTIONING CABLE LUMENS. NO DAMAGE WAS NOTED ON THE CABLE COATINGS IN ANY ABRASION ZONE. ELECTRICAL TESTING DID NOT REVEAL ANY INDICATION OF CONDUCTOR FRACTURES. UPDATED FIELD SAFETY CORRECTIVE ACTION (FSCA) IMPLEMENTED IN NOVEMBER 2011 ((B)(4)) WITH UPDATED PATIENT MANAGEMENT RECOMMENDATIONS AND ESTIMATES OF FAILURES ASSOCIATED WITH ALL CAUSE INSULATION FAILURE ON RIATA AND RIATA ST SILICONE ENDOCARDIAL DEFIBRILLATION LEADS, WITH A SPECIFIC EMPHASIS ON EXTERNALIZED CONDUCTORS. ST. JUDE MEDICAL VOLUNTARILY AND PROACTIVELY STOPPED SELLING RIATA AND RIATA ST SILICONE DEFIBRILLATION LEADS IN DECEMBER 2010. NO RIATA AND RIATA ST SILICONE ENDOCARDIAL LEADS INCLUDED IN THE FSCA HAVE BEEN DISTRIBUTED POST THIS CORRECTIVE ACTION. ALL CONCERNED COMPETENT AUTHORITIES WERE NOTIFIED ABOUT THIS ACTION AT THE TIME. UPDATED INFORMATION REGARDING PERFORMANCE OF RIATA AND RIATA ST SILICONE DEFIBRILLATION LEADS CAN BE FOUND ON WWW.RIATACOMMUNICATION.COM.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669182 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. 7042/60 2983708

    Patients

    Seq Age Sex Outcome Treatment
    1